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SNCTP000003485 | DRKS00017037 | BASEC2018-01973

Eine randomisierte, doppelblinde, placebokontrollierte, Studie zum Einfluss von Doxycyclin auf aversives Gedächtnis in Gesunden

Data source: BASEC (Imported from 25.09.2020), WHO (Imported from 20.09.2020)
Changed: 16.09.2020
Disease category: Mental and Behavioural diseases

Brief description of trial (Data source: BASEC)

Aversives Lernen liegt Erkrankungen wie der spezifischen Phobie oder der posttraumatischen Belastungsstörung zugrunde. In dieser Studie wollen wir untersuchen, ob sich durch das Antibiotikum Doxycyclin das aversive Gedächtnis beeinflussen lässt. Doxycyclin wirkt nach Einnahme kurzfristig auf Eiweisse im Gehirn, die wahrscheinlich auch für die Gedächtnisbildung verantwortlich sind. 560 gesunde Probanden bekommen in dieser Studie entweder eine Dosis von 200 mg Doxycyclin oder eine identisch aussehende unwirksame Substanz (Placebo). Die Zuordnung erfolgt zufällig (randomisiert). Weder Ihnen noch uns ist während der Durchführung der Studie bekannt, ob Sie Doxycyclin oder die unwirksame Substanz erhalten (Doppelverblindung)

Health conditions investigated (Data source: BASEC)

Wir führen diese Studie durch, um die Gehirnmechanismen kennenzulernen, die das aversive Gedächtnis beim Menschen steuern. Aversives Gedächtnis ist ein Modell für Angsterkrankungen wie z. B. spezifische Phobien.

Health conditions (Data source: WHO)

healthy subjects

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Wir untersuchen das Antibiotikum Doxyclin, das zur Malariaprophylaxe auch von gesunden Menschen häufig eingenommen wird. Diese Substanz wirkt möglicherweise auf die Aktivität gedächtnisrelevanter Eiweisse im Gehirn ein.

Interventions (Data source: WHO)

Intervention 1: Vibramycin® Tabs (Doxycyline), 200mg capsule, oral administration, single-dose.

6 experiments will examine whether aversive memories of healthy participants can be influenced by the antibiotic doxycycline. The experiments will be conducted over the time span of several days, however, the medicament will only be taken once, either at the time of memory consolidation or reconsolidation. Intervention 2: Placebo Mannitol PhEur (Perlitol 200SD)
200mg capsule, oral administration, single-dose

Criteria for participation in trial (Data source: BASEC)

Es können alle gesunden Personen zwischen 18 und 40 Jahren teilnehmen.

Exclusion criteria (Data source: BASEC)

(1) Aktuelle Erkrankung.
(2) Frühere neurologische, psychiatrische oder systemische Erkrankung
(3) Aktueller oder früherer regelmässiger Gebrauch von abhängig machenden Substanzen (z. B. Alkohol oder Drogen).

Inclusion/Exclusion Criteria (Data source: WHO)

Inclusion criteria: - Informed Consent as documented by signature
- Age 18 – 40 years
Exclusion criteria: • Allergy to doxycycline or to any other ingredient in the named drugs
• Use of any drugs in the 2 weeks prior to the study with the exception of contraceptive drugs and incidental use of NSARs or paracetamol
• Women who are pregnant or breast feeding,
• Intention to become pregnant during the course of the study,
• Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration
• Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
• Any history of psychiatric, neurological, addiction, or systemic/rheumatic disease
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the procedures of the study, e.g. due to language problems
• Participation in another study with investigational drug within 30 days preceding and during the present study,
• Previous enrolment into the current study,
• Members of the study team and their family members and dependants
• Regular work in a medical profession
• Life time history of being a victim of interpersonal violence or other potentially traumatic experience, or close relative of a person with such history

Further information on the trial in WHO primary registry

http://www.drks.de/DRKS00017037

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00017037

Further information on trial

Date trial registered

05.11.2019

Incorporation of the first participant

29.10.2019

Recruitment status

Recruiting

Academic title (Data source: WHO)

A randomised, double-blind, placebo-controlled study on the impact of doxycycline on aversive memory in healthy individuals - DoxAv

Type of trial (Data source: WHO)

interventional

Design of the trial (Data source: WHO)

Allocation: Randomized controlled trial;. Masking: Blinded (patient/subject, investigator/therapist). Control: Placebo. Assignment: Parallel. Study design purpose: Basic research/physiological study

Phase (Data source: WHO)

N/A

Primary end point (Data source: WHO)

Primary endpoints are updated prompt to the start of a new experiment.
Experiment 1:
Fear-potentiated startle, measured via eyeblink EMG of the M. orbicularis oculi and quantified according to Khemka et al. (2017)

Experiment 5:
Quantity and distress of intrusion in an intrusion diary during one week following the trauma film

Secundary end point (Data source: WHO)

Experiment 1:
SCR (skin conductance response), respiration amplitude, heart period measured with ECG (Electrocardiogram), pupil reaction, neuropsychological tests (e.g. VLM-T), questionnaires (STAI).

Experiment 5:
Questionnaires (e.g. STAI, BIS-BAS), SCR (skin conductance response), respiration amplitude, heart period measured with ECG (Electrocardiogram), neuropsychological tests (e.g. VLM-T).

Contact information (Data source: WHO)

Universität Zürich

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Zurich

Countries (Data source: WHO)

Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Erich Seifritz
+41443842312
erich.seifritz@bli.uzh.ch

Contact for general information (Data source: WHO)

Jelena
Wehrli
Lenggstrasse 31
Department of Psychiatry, Psychotherapy, Psychosomatics, University of Zurich
+41 44 384 26 60
jelena.wehrli@bli.uzh.ch

Contact for scientific information (Data source: WHO)

Birgit
Kleim
Lenggstrasse 31
Department of Psychiatry, Psychotherapy, Psychosomatics, University of Zurich
+41 44 384 23 51
b.kleim@psychologie.uzh.ch

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Department of Psychiatry, Psychotherapy, Psychosomatics, University of Zurich

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Zürich

Date of authorisation by the ethics committee

16.05.2019

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2018-01973

Secondary ID (Data source: WHO)

SNCTP000003485
KEK2018-01973